What side effects are associated with this type of intervention?

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) include the anti-fibrotic agents nintedanib and pirfenidone. Nintedanib is associated with gastrointestinal side effects such as diarrhea, nausea, and vomiting, as well as liver enzyme elevations. Pirfenidone commonly causes gastrointestinal issues like nausea and dyspepsia, skin rash, and photosensitivity. Both medications may also lead to fatigue and weight loss. These side effects are generally manageable with dose adjustments and supportive care.

What prior FDA approvals exist?

The FDA has approved two primary anti-fibrotic agents for the treatment of Idiopathic Pulmonary Fibrosis (IPF): nintedanib and pirfenidone. Nintedanib, approved for IPF, systemic sclerosis-associated interstitial lung disease (SSc-ILD), and other progressive fibrosing interstitial lung diseases, works by inhibiting multiple tyrosine kinases involved in the fibrotic process. Pirfenidone, also approved for IPF, reduces lung fibrosis through anti-inflammatory and anti-fibrotic mechanisms. Both drugs have shown efficacy in slowing the decline in forced vital capacity (FVC) in patients with IPF.

What other types of research exist?

Promising novel alternatives to INS018_055 for IPF treatment in 2024 include: 1) Pirfenidone, which has shown efficacy in slowing disease progression and reducing mortality. 2) Nintedanib, which also slows disease progression and is effective in advanced disease stages. 3) Pamrevlumab, an anti-connective tissue growth factor therapy, which has shown potential in clinical trials. 4) BAY-545, a novel non-xanthine antagonist of the A2B adenosine receptor, demonstrated efficacy in lung fibrosis models.

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INS018_055 for Idiopathic Pulmonary Fibrosis

Phase 2

Waitlist Available

Research Sponsored by InSilico Medicine Hong Kong Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial tests a new oral medication, INS018_055, in adults with Idiopathic Pulmonary Fibrosis (IPF). It aims to see if the medication is safe and well-tolerated over a few months.

Who is the study for?

Adults over 40 with Idiopathic Pulmonary Fibrosis (IPF) who meet specific lung function criteria can join this trial. They must have a stable condition and not have had an acute IPF exacerbation in the last 4 months. Smokers or those unwilling to quit, pregnant or nursing women are excluded.

What is being tested?

The study is testing INS018_055, taken orally for up to 12 weeks, against a placebo to see if it's safe and tolerable for adults with IPF. Some participants may also be on stable antifibrotic therapy like pirfenidone or nintedanib.

What are the potential side effects?

While the side effects of INS018_055 aren't listed here, common ones in trials might include gastrointestinal issues, skin reactions, fatigue, and potential liver enzyme changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: INS018_055Experimental Treatment1 Intervention

Group 1: INS018_055 once daily up to 12 weeks, low dose Group 2: INS018_055 twice daily up to 12 weeks, low dose Group 3: INS018_055 once daily up to 12 weeks, high dose

Group II: PlaceboPlacebo Group1 Intervention

Group 4: Placebo once or twice daily up to 12 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INS018_055

2022

Completed Phase 2

~150

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) are the antifibrotic agents nintedanib and pirfenidone. Nintedanib works by inhibiting multiple tyrosine kinases involved in the pathways that lead to fibrosis, thereby slowing disease progression. Pirfenidone exerts its effects through anti-fibrotic and anti-inflammatory mechanisms, reducing the production of fibrotic mediators and slowing lung function decline. These treatments are crucial for IPF patients as they help to manage symptoms, slow disease progression, and potentially improve survival. Emerging treatments like INS018_055, which may have anti-fibrotic or anti-inflammatory properties, are being studied to provide additional therapeutic options and improve patient outcomes.

TGF-beta-induced EMT: mechanisms and implications for fibrotic lung disease.